Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients

Not Applicable

• Conditions: Neurodegenerative Diseases
• Interventions: Dietary Supplement: ROO; Dietary Supplement: EVOO-C

• Registration Number: NCT04229186
• Lead Sponsor: University of Bari Aldo Moro

Brief Summary

Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.

Detailed Description

24 MCI or Alzheimer's Disease patients will be recruited and randomised; 12 of them will receive extra virgin olive oil "coratina" (EVOO-C); 12 of them will receive biophenol low dose olive oil (ROO). Each patient will consume a total amount of 10 mg olive oil in a year (12 months). Clinical assessement will be based on:

* neurological examination (T0, T6, T12);

* cardiological examination (T0, T12): a supra-aortic vessels and brachial artery ecocolordoppler will be performed;

* ophthalmological evaluation (T0, T12): a optic coherence tomography will be performed;

* neuropsychological assessment (T0, T12);

* nutritional assessement(T0, T3, T6, T9, T12).

Each subject will perform:

* brain MRI (T0, T12);

* Beta Amyloid Positron Emission Tomography (T0, T12) A lumbar puncture will be ruled as well (T0) and markers of neurodegeneration (Beta-amyloid 1 - 42, total tau protein, fosfo-tau, Brain Derived Neurotrophic Factor (BDNF), Neurofilament (NFL) will be quantified); Renal, hepatic and nutritional status will be assessed 3 times in 12 months (T0, T6, T12).

Study Timeline

• Study First Submitted: 2019-09-23
• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted QC: 2020-01-11
• Last Update Submitted: 2020-01-11
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• MCI diagnosis in the last month prior the recruitment;
• Clinical Dementia Rating Scale - Global Score (CDR - GS) 0,5 and Mini Mental Examination 24 - 27;

Exclusion Criteria

• smoke;
• hypertension;
• diabetes;
• positive history of stroke, epilepsy or cardiac disease;
• BMI > 30;
• depression or other psychiatric disturbances;
• low compliance to medical interventions;
• positive history of olive oil allergy or intolerance;
• positive history of chronic inflammatory intestinal disease or malabsorption;
• positive history of maculopathy or retinopathy;
• MRI leukoaraiosis II-III grade Fazekas or MRI lacunar infarctions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with assumption of ROO	ROO	12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO
Patients with assumption of EVOO-C	EVOO-C	12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C

Primary Outcome Measures

Name	Time	Method
Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.	Change from baseline neurodegenerative biomarkers at 12 months	Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analysis (cerebrospinal level of Beta-amyloid, Tau and phosphotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))
Evaluate the change of optic nerve and macula thickness after olive oil supplementation.	Change from baseline optic nerve and macula thickness at 12 months	Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)
Evaluate the change of nutritional parameters after olive oil supplementation	Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months	Weight and height will be combined to report BMI in Kg/m\^2. Nutritional assessment will be measured comparing the variation of BMI of each patient during the follow up.
Evaluate the change of cerebral performance after olive oil supplementation.	Change from baseline MMSE score at 12 months	The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)
Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.	Change from baseline at 12 months	Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)
Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.	Change from baseline BAPL at 12 months	Beta amyloid positron emission tomography will be performed measuring a index called BAPL.